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Completed

NCT Number: NCT01048437

Educating Missouri Patients About Preemptive Living Donor Transplantation

This study is a group-randomized controlled trial to explore whether improved community transplant education for renal patients not yet on dialysis could increase patients' willingness to pursue preemptive living donor transplant (PLDT) and PLDT rates.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Missouri Kidney Program, Overland Park, Kansas, United States

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About this study

Preemptive living donor transplant (PLDT), where renal patients get a living donor transplant before their kidneys fail, has better graft survival and lower mortality rates than living donor transplant following dialysis. However, not all renal patients and their living donors know about or consider living donation before a patient starts dialysis; To date, patients and donors presenting for PLDT are more likely to be Caucasian, of higher socioeconomic status, and more knowledgeable about transplant. To reach all patients newly diagnosed with kidney disease, the Missouri Kidney Program conducts a community Patient Education Program (PEP) outlining patients' transplant and dialysis options. Since 1994, approximately 2000 Missouri patients newly diagnosed with kidney disease and their family members have attended 2-day PEP classes. However, the current PEP transplant module does not significantly increase patients' willingness to pursue PLDT. Through a previous HRSA grant, Dr. Waterman designed the "Explore Transplant" education program based on Prochaska's Transtheoretical Model of Behavioral Change and her previous research to address key gaps in patients' living donation knowledge and to motivate patients to consider living donation. If funded, this study would conduct a group-randomized controlled trial to explore whether improved community transplant education for renal patients not yet on dialysis could increase patients' willingness to pursue PLDT and PLDT rates. Secondary objectives of the study are: (2) to increase rural and minority patients' access to transplant education, and (3) to describe racial, social, economic, and other influences affecting patients' PLDT willingness. The study design is a group-randomized controlled trial of 300 patients in 30 PEP classes in St. Louis, Springfield, and Kansas City, MO; patients and their family members in 15 classes will be randomized to receive the "Explore Transplant" education module, while 15 control classes will receive the traditional PEP transplant education. Across the education and control PEP classes we will compare: (1) increased willingness to pursue PLDT using baseline and follow-up attitudinal patient surveys, and (2) rates of living donation by tracking whether patients and their living donors present to any Missouri transplant center. At the conclusion of the study, we will have learned important information about how to reach and educate patients who have not yet begun dialysis and have developed a PLDT program that could be utilized in physicians' offices and by other organizations serving renal patients to increase living donation rates.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic kidney disease
  • Attend all 6 education modules
  • 18+ years of age
  • Have given consent by signing informed consent
  • Speak and understand English
  • Can read and understand questionnaires

Exclusion criteria

  • Patients who do not speak and understand English (material is presented orally)
  • Patients who cannot read and understand the questionnaires
  • Patients who are 17 years of age or younger

Treatment and study plan

Transplant education with video

Behavioral

1 hour standard transplant module is replaced with the Explore Transplant presentation and 20 minute video featuring transplant patients and donors

Transplant education with speakers

Behavioral

1 hour standard transplant module is replaced with the Explore Transplant presentation and 3 live speakers: 1 deceased donor recipient, 1 living donor recipient and 1 living donor

Primary outcomes

  1. Willingness to pursue preemptive living donor transplant

    Time frame: pre and post-class

Secondary outcomes

  1. Preemptive living donor transplant rates

    Time frame: 1-2 years

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Health Resources and Services Administration (HRSA)
  • Missouri Kidney Program

Registry information

Official study title

Educating Missouri Patients About Preemptive Living Donor Transplantation: A Randomized Controlled Trial

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 13, 2010
Registry last updated
Sep 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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